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Update on Medication Issues

Update on Medication Issues. Dan Fick Racing Medication & Testing Consortium. Mission of RMTC. Formed in 2002 as a 501 (c) (3) charitable organization To develop, promote and help coordinate, at the national level, policies, research and educational programs that seek to:

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Update on Medication Issues

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  1. Update on Medication Issues Dan Fick Racing Medication & Testing Consortium

  2. Mission of RMTC • Formed in 2002 as a 501 (c) (3) charitable organization • To develop, promote and help coordinate, at the national level, policies, research and educational programs that seek to: • ensure fairness and integrity of racing • ensure the health and safety of racehorses and participants • protect the interests of the racing public

  3. AAEP AQHA Arabian Jockey Club Breeders’ Cup California TB Trainers Churchill Downs Del Mar Hambletonian Society Harness Tracks of America     Jockeys’ Guild Keeneland Kentucky TB Association Magna Entertainment National HBPA National Steeplechase NTRA NYRA Oak Tree RCI THA The Jockey Club TOBA TB Owners of California TRA TRPB USTA Participation Organizations on the Board of Directors

  4. Topics • Penalties • Lasix • NSAID • Anabolic Steroids • Corticosteroids • International Harmonization • Drug Testing Initiative • Security

  5. Penalties and the Model Rules Old Version: • Penalties were based on RCI Class of the drug. • Classification based on pharmacology of drug. • Penalties had large ranges for number of suspension days and amount of fines. • No guidance on how treat multiple violations and extenuating circumstances, either mitigating or aggravating.

  6. Penalties and the Model Rules Reasons for change: • Consideration should be whether the drug is appropriate to see in a racehorse on race day. • Penalties should increase with intent, severity and repeat violations. • Other licensees should participate in the penalty phase especially repeat violators. • We need to define possible mitigating and aggravating circumstances.

  7. Extenuating Circumstances • Past record of trainer, veterinarian and owner in drug cases. • Potential of drug(s) to influence a horse’s racing performance. • Legal availability of the drug • Whether there is reason to believe the responsible party knew of the administration of the drug or intentionally administered the drug. • Steps taken by the trainer to safeguard the horse.

  8. Extenuating Circumstances • Probability of environmental contamination or inadvertent exposure due to human drug use. • Purse of the race • Whether the drug found was one for which the horse was receiving a treatment as determined by the Medication Report Form. • Whether there is any suspicious betting pattern in the race. • Whether the licensed trainer was acting under the advice of a licensed veterinarian.

  9. Flunixin (Banamine) RCI Class 4 NSAID FDA-approved for the horse Many studies in the scientific literature in the horse Regulated by rule Meloxicam RCI Class 4 NSAID Not FDA-approved for the horse No scientific studies in the horse Not regulated by rule Penalties and the Model Rules • So, the question is why would someone • use Meloxicam instead of Flunixin?

  10. Penalties and the Model Rules New Version: • All RCI Drugs categorized into A, B, C or D groups. • Each drug was slotted based on criteria: • FDA approval…1st for horse, 2nd for any reason? • Potential to enhance race day performance? • Legitimate therapeutic application? • Identified as necessary by RCI Regulatory Veterinarian Committee? • Does an alternative exist? • What is the current RCI Classification?

  11. Diclofenac (Surpass) FDA-approved? Yes, for the horse Performance? Minimal Legitimate therapeutic application? Yes, as a topical anti-inflammatory Identified as necessary? Yes Does an alternative exist? No Current RCI Class? 4 Penalty Class “C” $500 fine & loss of purse Meloxicam FDA-approved? No for horse, yes for human Performance? Yes Legitimate therapeutic application? No, no research Identified as necessary? No Does an alternative exist? Yes…Flunixin, Bute, Ketoprofen Current RCI Class? 4 Penalty Class “B” 15 day suspension, $1000 fine & loss of purse Penalties and the Model Rules

  12. Penalties and the Model Rules Other Aspects: • Ability to penalize veterinarian to same extent as trainer if culpability can be proven. • Licensed owners to be notified of any hearings as a result of a violation. • Penalties for owner and horse potentially. • Flexibility to let the penalty fit the circumstances of the case…not uniform penalties but a uniform approach to penalties. • RCI Model Rules: http://ag.arizona.edu/rtip/

  13. Furosemide (Salix/Lasix) • 90+% of horses suffer from some degree of EIPH, estimated that industry cost of EIPH approaches $100 million dollars. • Working theory is that increase in circulating red blood cells during exercise increases pressure in capillaries and vessels of lung. • Furosemide thought to lower blood pressure in lungs by reducing fluid component of blood. • Published science was not seen by many as definitive on whether this is the case or not.

  14. Furosemide (Salix/Lasix) Lasix Perceptions • We are breeding generations of bleeders. • Lasix masks the presence of other drugs. • Lasix is somehow linked to soundness issues.

  15. Furosemide (Salix/Lasix) South African Study (2008): • Double-blind study using horses that had never received Lasix before a race. • Raced twice under same exact conditions two weeks apart – jockey, post, distance, competition, purse. • Horses receiving saline instead of Lasix had increased severity of EIPH. • 67.5% of horses that bled when receiving saline had improved EIPH severity scores (1-4) by one. • Conclusion…EIPH incidence and severity was improved by pre-race administration of Lasix. • Cost: $1,000,000+

  16. NSAIDS • One of three – Phenylbutazone, Flunixin, Ketoprofen – can be administered at 24 hours before post time of the race. • Must be administered with single IV injection • Recommended Threshold concentration used to enforce the Model Rule: • 20 ng/ml for Flunixin • 10 ng/ml for Ketoprofen • 5 mcg/ml for Phenylbutazone • Research studies had indicated analgesic effect entirely gone by 24 hours after IV injection.

  17. NSAIDS • Most regulatory veterinarians believe the 24-hour administration impacts their ability to perform pre-race exams at 4-10 hours before the race. • Research study results are mixed on this time frame. • Some states lax in enforcement of 24-hours – 6PM. • Blood samples recently collected in CA & KY at the time of the pre-race exam show levels significantly above threshold limits. • At RCI April Convention RMTC Board will consider recommendations for 48-hour rule (Canada), and/or reducing Bute threshold to 2 mcg/ml.

  18. Anabolic Steroids • Model rule has been in place now for 6-18 months depending on jurisdiction. • Rule has basically eliminated the use of the usual anabolic steroids in racing and training. • Chemists reporting no detectable anabolic agents in post-race samples. • Revised Model Rule with plasma thresholds proposed to RCI – limit of detection 25pg/ml. • Labs with proper instrumentation will likely switch to plasma testing with LC/MS.

  19. Anabolic Steroids Issues • The program gelding with high testosterone • Recommend a HCG Challenge Test to determine whether residual testicular tissue. • If “positive” horse is classified for regulatory purposes as a “rig” and kept as a gelding for program. • “Rig” notation is sent to lab with subsequent samples which are excused from testosterone testing. • Hermaphrodites • One Standardbred mare on east coast throws fillies with internal male sex organs.

  20. Anabolic steroids Starting to see “replacement” substances begin to be a problem: • High-dose Mexican Clenbuterol • Ractopamine • Ethylestrenol • Factrel

  21. Corticosteroids • RCI Class 4 Substances - Anti-inflammatory • Very diverse group of drugs; wide number of uses. • Difficult to test; complicated by multiple routes of administration. • Intra-articular administrations within 72 hours – waiting to see if horse draws into race. • Many states choose to use testing budget elsewhere mostly due to Class 4 status. • Abuse, particularly inter-articular is significant especially in claiming and Quarter Horses.

  22. Corticosteroids • Pennsylvania has adopted a 7-day ban on intra-articular injections. • New York has a 5-day ban. • AAEP is considering 5-10 day recommendation. • Questions as to whether these rules can be enforced with current testing methodologies. • RMTC is requesting proposals on corticosteroid research on pharmacokinetics, withdrawal times and dynamic markers.

  23. International Harmonization • Joint meeting of RMTC & IFHA Advisory Council on Prohibited Substances in April 2009 at RCI. • RMTC signed a non-disclosure agreement with EHSLC. • USA attendance for first time ever at EHSLC meeting in Newmarket in July 2009. • We have a much better understanding of each others approaches and issues.

  24. International Harmonization • USA, IFHA and EHSLC sharing priority lists for administration studies and resulting data produced. • Interest from EHSLC & IFHA on cooperative research on administration studies in multiple jurisdictions. • USA & IFHA meeting at March ICRAV in NZ and EHSLC meeting in July in Ireland. • Dispelling perception that USA racing is over medicated and international racing is drug free.

  25. Drug Testing Initiatives Post-race testing in the United States: • Currently 18 laboratories conducting testing in USA. • Only six labs are ISO 17025 accredited • 30% of samples were tested by an accredited lab in 2008. • 2008 RMTC Lab Survey: Funding and methodology are dramatically different state-to-state. • No uniform industry standards for USA testing labs. • Animal selection strategies has not changed in years. • Financially limited industry quality assurance programs until 2009.

  26. Drug Testing Initiatives • DTI Task Force of leading chemists with RMTC & RCI representatives formed in September 2008. • Goal: “Design the best system for USA Drug Testing irrespective of funding and politics.” • Utilized laboratory standards developed by the World Anti-Doping Association (WADA) and AORC ILAC-G7 where applicable working towards the development of a performance-based system. • Other related topics discussed…next generation of lab directors, sample selection, frozen samples, harmonization nationally and internationally.

  27. Drug Testing Initiatives Creation of Industry Standards for Labs: • Edited version of WADA Lab Accreditation Program has been completed by DTI Task Force. • Uniform Lab Standards was the first step. • Equine Quality Assurance Program is next by July 1. • EQAP and laboratory accreditation required in state racing commission drug testing RFP’s by 2012? • 10% of laboratory budgets are mandated to be directed towards research. • Current QAP program (TIP) expanded for 2009-2010 by RMTC to prepare for transition to 3rd party EQAP.

  28. Drug Testing Initiatives Creation of Industry Standards for Labs • States/industry now has a document to “sell” to legislatures in order to provide funding for drug testing laboratories to meet DTI standards. (NY) • Industry will also need funding for the industry organization that takes on the role of WADA. • RMTC is currently the “place-holder”. • Could be a perfect fit for concept of a national interstate racing regulatory compact.

  29. Drug Testing Initiatives Post-doctoral and grad student recruitment: • Laboratory directors are aging…who replaces them? • Those with research programs that are racing related could do more with capable students. • Developing a comprehensive program to target individuals with pharmacology/veterinary/chemistry backgrounds to place in research positions and will also utilize racing laboratories and possibly U of A RTIP for broader racing education. • Initial cost: $150,000 per year for two positions • RMTC has pledged $75,000 per year.

  30. Drug Testing Initiatives • Sample Collection • Is testing winners the most efficient use of testing dollars? • 1991 McKinsey Report recommended testing 50% of winners and specials based on odds and finish. • Possibility of collection without testing. • Frozen Sample & Retro-Testing Program • Possible deterrent effect and useful for intelligence information. • Program funded by The Jockey Club for 2009-2010 with RMTC as administrator (UC-Davis).

  31. Big Event Security Team • TRPB/SIS & RMTC joint venture • Team of investigators at major racing events • 2005 Kentucky Derby was 1st event. • All breeds: Little Brown Jug & Los Alamitos • Three years BET was at 25+ major events. • Many horsemen appreciated increased security. • RMTC support discontinued in 2008 as not part of RMTC mission.

  32. Security Manual • TRPB/SIS & RMTC joint effort • Detailed instructions for security personnel training. • Power point presentation • DVD • Distributed to all racetracks in 2007. • Needs to be updated.

  33. Barn Area Security • TRPB Security Assessment Program • RMTC joint effort in 2006-2008 • Stable Area Security Assessment Protocols • Offered free to TRA and USTA tracks • Very limited participation • NTRA Safety & Integrity Alliance Track Certification Requirement • AAEP Racing Task Force recommendation: “More backstretch security” • Racetrack Chaplain as a resource.

  34. Consultation and Contraband Testing RMTC 821 Corporate Drive Lexington, KY 40503 rallison@rmtcnet.com (859) 224-2844 www.rmtcnet.com

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